SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence

PHASE1CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

May 31, 2018

Study Completion Date

August 31, 2018

Conditions
Clostridium Difficile Infection
Interventions
DRUG

SER-262

SER-262 is a rationally designed, multi-strain Ecobiotic® microbiome therapeutic produced synthetically by in vitro fermentation. It is a consortium of anaerobic, commensal bacteria in spore form, encapsulated for oral administration.

DRUG

Placebo

Placebo will be identical to the investigational product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.

Trial Locations (22)

10467

Montefiore Medical Center, The Bronx

14642

University of Rochester Medical Center, Rochester

21401

Anne Arundel Health System Research Institute, Annapolis

24501

Infectious Disease Associates of Central Virginia, Lynchburg

30281

Clinical Research Atlanta, Stockbridge

30322

Emory University Hospital, Atlanta

32810

Omega Research Consultants, Orlando

33015

San Marcus Research Clinic, Inc., Miami

35749

North Alabama Research Center, LLC, Athens

43215

Remington Davis, Columbus

45801

Regional Infectious Diseases & Infusion Center, Lima

48202

Henry Ford Health System, Detroit

55902

Mayo Clinic, Rochester

59701

Mercury St. Medical Group, Butte

63141

Sundance Clinical Research, LLC, St Louis

68114

Quality Clinical Research, Omaha

76508

Baylor Scott & White Research Institute, Temple

83404

Snake River Research, Idaho Falls

84010

Dr. Hansen Internal Medicine, Bountiful

91942

eStudySite, La Mesa

92708

Lalla-Reddy Medical Corporation, Fountain Valley

07753

Jersey Shore University Medical Center, Neptune City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pharm-Olam International

INDUSTRY

lead

Seres Therapeutics, Inc.

INDUSTRY

NCT02830542 - SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence | Biotech Hunter | Biotech Hunter